The Trendlines Group (Trendlines) (SGX:42T) announced that its portfolio company, Vensica Medical, has secured the clearance from the US Food Drug Administration (FDA) on its investigational new drug (IND) application to initiate a Phase two clinical trial of ViXe.
According to Trendlines, the study will evaluate Vensica’s Vibe ultrasound-based, needle-free drug delivery system in combination with Xeomin for the treatment of overactive bladder (OAB).
Trendlines believes that the Phase two study will enrol approximately 210 patients across United States and Europe and this milestone triggers a contractual development milestone payment from its strategic partners.
Vensica Medical is supported by numerous investors and strategic partners, including Merz Pharma, Laborie, Israel Biotech Fund and Trendlines.
“We believe ViXe has the potential to overcome the barriers of needle-based delivery and deliver meaningful impact in urologic healthcare,” says Vensica Medical’s CEO, Avner Geva.
“This clearance represents a key milestone in Vensica Medical’s development and follows a number of key developments recently in our portfolio, emphasising the progress and maturity of our companies,” adds Haim Brosh, CEO of Trendlines.
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Shares in Trendlines closed flat at 6.2 cents on May 4.
